Safety, Efficacy and Pharmacokinetic Study of PRLX 93936 in Patients With Multiple Myeloma

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To determine the maximum tolerated dose of, and response to, PRLX 93936 as treatment for patients with relapsed or relapsed/refractory multiple myeloma.

Condition or disease

Intervention/treatment

Phase

Multiple Myeloma

Drug: PRLX 93936

Phase 1Phase 2

Detailed Description:

To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of PRLX 93936 administered IV 3 days a week (Monday, Wednesday and Friday) for 3 weeks followed by a 9 day rest period, as treatment for patients with relapsed or relapsed/refractory multiple myeloma.

To establish the dose of PRLX 93936 recommended for future studies.

To characterize potential toxicities of PRLX 93936.

To assess the pharmacokinetic profile of PRLX 93936.

To evaluate response to treatment, time to response (TTR) and duration of response.

Phase 1/2, Multi-center, Open Label, Dose Escalation, Safety, Efficacy and PK Study of PRLX 93936 Administered IV 3 Days a Week for 3 Weeks Followed by a 9 Day Rest Period in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patient must have a diagnosis of multiple myeloma and have relapsed or relapsed/refractory disease.

Patient must have received ≥ 2 prior anti-myeloma regimens including a proteasome inhibitor and/or immunomodulatory agent.

Patient currently requires systemic therapy.

Patient has measurable disease.

Age ≥ 18 years

Karnofsky performance status ≥ 60%

ECOG performance 0, 1 or 2

Life expectancy of at least three months

Able to take acetaminophen

Not pregnant

Patient must have recovered from toxicities incurred as a result of any previous anti-myeloma therapy or recovered to baseline.

Patients who received an autologous stem cell transplant must be ≥ 3 months post-transplant and all associated toxicities must have resolved to ≤ CTCAE Grade 1.

Patient received chemotherapy or other anti-cancer therapy that may be active against multiple myeloma within 3 weeks prior to the first dose of PRLX 93936.

Patient received nitrosureas within 6 weeks prior to the first dose.

Patient received corticosteroids within 2 weeks prior to the first dose.

Patient received plasmapheresis within 4 weeks prior to the first dose.

Patient had major surgery within 4 weeks prior to the first dose.

Patient had an allogeneic stem cell transplant within 6 months before first dose of PRLX 93936 or has evidence of graft versus host disease.

Patient is taking any therapy concomitantly that may be active against multiple myeloma.

Patient is currently receiving medication(s) that are principally metabolized via the cytochrome P450 3A4 enzyme pathway.

Use of any investigational agents within 28 days or 5 half-lives (whichever is shorter) of study treatment.

Patient has peripheral neuropathy of Grade 3 or greater intensity, or painful Grade 2, as defined by the NCI CTC.

Patient had a myocardial infarction within 6 months of enrollment or has NYHA Class III or IV heart failure uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.

Abnormal LVEF (< LLN for the institution for a patient of that age) on echocardiogram

Patient has poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to protocol.

Patient had a malignancy other than multiple myeloma within 3 years before enrollment, with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, or in situ prostate cancer.

Patient's clinical laboratory values meet any of the following criteria within the 7 days prior to Study Day 1: